Delphi Medical Systems' Quality System is woven throughout the entire organization, from the assembly line to material program managers and engineers to executive management.

Quality Foundation:

• Your product will always be manufactured according to documented/approved quality processes and practices
• Your product will always meet your expectations through:
- Quality Plans to provide that the product meets all its requirements, including regulatory requirements
- Rigorous test and inspection processes
- Engineering change control
- Flawless execution of manufacturing, test and inspection procedures driven by our comprehensive employee training
- History records that document your product meets its requirements

Certifications:

• ISO 9001:2000 certified
• ISO 13485:2003 certified
• QSR (cGMP) compliant

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Customer Satisfaction: Customer satisfaction is our primary business goal, and the ability to measure this instrumental element is paramount to Delphi's commitment to continuous improvement. We build customer satisfaction with:

• weekly conference calls and monthly meetings with customers to keep them abreast of their programs
• surveys to gather our customers' perceptions of Delphi's quality, service, delivery, technology, communications and overall performance

Documentation: Delphi sets the industry standard for comprehensive documentation. Delphi engineering and manufacturing experts document with:

• digital images of the manufacturing and test processes
• clear descriptions of how to build products and measure product quality

Quality Plans: The Assembly Quality Plans (AQPs) and the Component Quality Plans (CQPs) identify all of the qualitative and quantitative measurements from the product components to the subassemblies and complete systems.